Dynamic surgical implant

ABSTRACT

A surgical implant device capable of conforming to a variety of surface topographies facilitates the growth and regeneration of site to which the device is applied. The device employs a plurality of elongate members supporting a column of discrete, rotatable elements in contact with each adjacent element. Anchor plates secure the respective ends of the elongate members, such anchor plates attachable to bone. The implant device provides and ordered array of individually rotatable elements to form a surface that permits bodily fluids to pass therethough.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of applicationSer. No. 12/975,577, filed Dec. 22, 2010, the entire disclosure of whichis hereby fully incorporated by reference as part of the presentapplication.

FIELD OF THE INVENTION

The present disclosure relates generally to a device and method of usefor an implantable apparatus for use in surgery. More specifically, thepresent disclosure relates to a conformable yet semi-rigid material forimplanting into a patient and stabilizing, for example, an anatomicalfeature such as a bone fracture site, pedicle, or intervertebral diskspace.

BACKGROUND OF THE INVENTION

It is current practice in orthopedic surgery to use plate and/or rodsystems for joining portions of a broken bone, or for fusion of portionsof separate bones. Such systems are composed essentially of plates, rodsand screws for aligning and holding the bone portions in a desiredposition relative to one another. Plate and rod systems have usefulnessin the spine, and have general skeletal use on the flat surfaces ofbones, such as the scapula and the pelvis by way of example, and for useon tubular bones, such as the humerus, radius, femur, and tibia.

Currently known plating systems present disadvantages to patients andsurgeons as they do not contemplate and/or allow for mass transfer toand from a site directly below or surrounding the plate. Thus,conventional plates typically impede the regeneration and osteosynthesisof the bone or tissue they are intended to heal. Additional problemsassociated with plating systems have included hardware breakage,hardware loosening, insufficient flexibility particularly over time,inability to gain adequate fixation, unnecessary additional weight, andother problems related to implant and recovery of the patient. Oneparticular problem is “distraction pseudoarthrosis” where the plate willnot allow the bone portions to come together over time resulting in afailure to get solid bone healing. These occurrences may cause problems,be associated with surgical failure, and require further surgicalprocedures to repair the damage, remove the failed hardware, and/or toreattempt stabilization of the boney anatomy.

Plates and rods are usually provided to the surgeon for use in setshaving a range of sizes so as to provide for such features as biologicalvariability in size, the numbers of segments to be joined, and thelength of the portions of bone to be joined. By way of example, it wouldbe common for a plating system for use on the anterior cervical spineand for joining from two to five vertebrae to comprise of from forty tosixty plates. This requires manufacturers to make a large number ofdifferent plates, resulting in increased manufacturing costs andinventory costs and increased costs for hospitals to stock large numbersof plates. Further, in the event that a plate is used and another of itskind is needed before it can be replaced, the ability to provide to apatient the best care could be compromised.

Known plate and rod systems additionally experience problems inconnection with those procedures where bone grafts are placed betweenvertebral bodies to achieve an interbody fusion which heals by a processcalled “creeping substitution.” In this process, dead bone at theinterfaces between the graft and the adjacent vertebra is removed by thebody, as a prelude to the new growth of bone forming cells and thedeposition of new bone. While the plates and rods allow for properalignment of the vertebrae and their rigid fixation, they can therefore,at the same time unfortunately, hold the vertebrae apart while theresorption phase of the creeping substitution process forms gaps in thebone at the fusion site with the result that the desired fusion does notoccur. Such failure in an attempted fusion is known as pseudoarthrosis.A similar phenomenon occurs at the interface of a fractured bone'sfragments and is known as non-union. When such a failure occurs, thehardware itself will usually break or become loosened over timerequiring further surgery to remove the broken hardware and to againattempt fusion or fracture repair.

There has been a long-felt and unmet need for an implant system whichprovides for required levels of strength, shock absorption, resistanceto stresses and strain, and yet still allows for compliance andflexibility in order to wrap or accommodate various non-planar implantsites, while still allowing for adequate mass transfer to and from theimplant site.

SUMMARY OF THE INVENTION

The present invention comprises a method and apparatus for a surgicalimplant system which further contemplates and allows for circulation ofair and liquids essential for growth, regeneration, and proper functionof a bioactive area to which the apparatus is to be applied. Theinvention comprises the ability to allow for sufficient breathabilityand passage of certain elements, thus enabling bone and tissue growthbeneath, around, and/or within the implant, and further providessufficient structural support in various directions. In one embodiment,the present invention comprises a malleable mesh-like device, similar toa breathable bandage, which is capable of conforming to a variety ofnon-planar implantation sites while still providing sufficient stabilityand resistance to certain forces.

In one embodiment, the present invention comprises a device for use inintervertebral connection, including a “ligament” or attaching member.In this embodiment, the device is secured by bone fasteners, such as,for example, first and second shoulderless bone fasteners connecting tothe first end portion of the ligament and the second end portion of theligament, respectively. The ligament has a conformable portion, which isformed by a series of filaments (e.g. wires) and segments (e.g.cylinders) having a hollow center through which a filament passes.

In another embodiment, a surgical implant for strengthening a bone orjoint is provided which comprises a plurality of individual parallelspaced wires extending from and affixed to a first anchor member and asecond anchor member. In this particular embodiment, each individualparallel spaced wire has a plurality of generally circular and/orcylindrical members surrounding each of the wires and the generallycircular members are freely rotatable about the wires. In an alternativeembodiment, the plurality of wires and plurality of generally circularmembers form a fabric-like structure that permits liquids to flowtherethrough and permits bone ingrowth when implanted adjacent to apatient's bone.

In yet another embodiment, the plurality of wires and plurality ofgenerally circular members comprise at least one biocompatible materialselected from the group consisting of ceramic, PEEK, titanium, stainlesssteel, stainless steel alloys and titanium alloys. The plurality ofwires and plurality of generally circular members may comprise aresorbable synthetic material.

In one embodiment, the wires have a diameter of about 0.01 mm to about 2mm and the generally circular members have a diameter of approximately0.250 inches and approximately 0.500 inches.

In yet another embodiment, the plurality of generally circular memberscontact adjacent generally circular members on an adjacent individualspaced wire.

In yet another embodiment, each of the first and second anchor membershas at least two apertures adapted to receive a screw.

In one embodiment, the plurality of wires comprise one of ceramic,titanium, stainless steel, stainless steel alloys and titanium alloysand the plurality of generally circular members comprises PEEK.

In another embodiment, the plurality of wires and plurality of generallycircular members have resilient and damping properties. For example, thegenerally circular members may be comprised of a material which iscapable of absorbing a certain amount of force or impact and deflectingor straining to a certain degree without plastically deforming.

In one embodiment, neither the plurality of wires nor the plurality ofgenerally circular members are interlocked with one another. In yetanother embodiment, the generally circular members comprise a pluralityof through holes formed therein.

In one embodiment, an appliance is provided for covering a surgery siteof a bone in vivo. The appliance comprises a flexible member adapted forcontacting the bone surface of a patient to promote healing of the bonesurface and surrounding bone and/or tissue. In this embodiment, themember has a first side and a second side adapted to face toward andaway from the bone, respectively. The member further comprises aplurality of wires and a plurality of generally circular members forminga fabric-like structure that permits liquids to flow therethrough andpermits bone ingrowth when implanted adjacent to a patient's bone. Themember has at least two closure edges proximate each other when themember is wrapped around the bone and includes connecting means,engaging the at least two closure edges, for connecting the closureedges to firmly hold the member around a bone. Connecting means mayinclude, for example, various staples, fasteners, clasps, sutures, pins,zippers, welds, crimping elements adapted for use with an appliance orimplant.

In an alternative embodiment, a pliable structure for use in surgery isprovided which comprises a pliable structure having a first face sideand a bone interface side and including a multiplicity of recessesprovided that permit in growth of bone therethrough. The structure hasgenerally uniformly shaped arcuate members positioned around a pluralityof wires spaced generally parallel to each other to form adjacent rowsof rotatable rows of arcuate members. In this embodiment, the structurefurther has a substantially uniform configuration about an interiorportion thereof, at least two periphery anchor sites adapted to connectto another portion of the member, or connect directly to a bone surfacevia one of a bone screw, bone staple or bone adhesive. As used herein,the term arcuate refers generally to members that have at least onecurved, rounded, or partially-rounded surface.

In another embodiment, the structure of the present invention isfabricated of biocompatible metals and metal alloys selected from thegroup consisting of titanium, titanium alloys, cobalt-chrome alloys andstainless steel. In another embodiment, the multiplicities of recessesare too small to receive a bone screw. In yet another embodiment, thefirst face side and the bone interface side are interchangeable.

The following references related to spinal implants, cage bodies,methods and devices for spinal correction, and intervertebral implantsand plates are known to be relevant to the field of the presentinvention and are hereby incorporated by reference in their entireties:U.S. Patent Application Publication No. 2010/0057208 to Dryer et al.,WO/2005/037150 to Martz et al., WO/2005/112835 to Serhan et al., U.S.Patent Application Publication No. 2007/0073293 to Martz et al., U.S.Patent Application Publication No. 20100063548 to Wang, U.S. Pat. No.7,662,185 to Alfaro et al., U.S. Patent Application Publication No.2009/0162643 to Dubrow et al., U.S. Pat. No. 7,651,497 to Michelson,U.S. Pat. No. 6,077,076 to Comfort, U.S. Pat. No. 6,827,743 to Eisermannet al., U.S. Pat. No. 7,655,047 to Swords, U.S. Pat. No. 4,502,161 toWall, U.S. Pat. No. 4,089,071 to Kalnberz et al., U.S. Pat. No.6,066,175 to Henderson et al., U.S. Patent Application Publication No.2006/0052873 to Buck et al., U.S. Pat. No. 5,766,176 to Duncan, U.S.Pat. No. 5,346,492 to Morgan, U.S. Pat. No. 5,443,483 to Kirsch, U.S.Pat. No. 7,658,766 to Melkent, U.S. Pat. No. 6,086,613 to Camino et al.,U.S. Pat. No. 7,670,375 to Schaller, U.S. Pat. No. 4,773,402 to Asher etal., U.S. Pat. No. 4,887,595 to Heinig et al., U.S. Pat. No. 5,113,685to Asher et al., U.S. Patent Application Publication No. 2009/0292365 toSmith et al., U.S. Patent Application Publication No. 2007/0100454 toBurgess et al., U.S. Pat. No. 7,344,539 to Serhan et al., U.S. Pat. No.7,229,441 to Trieu et al., U.S. Pat. No. 6,127,596 to Brown et al., U.S.Patent Application Publication No. 2008/0161855 to Serhan et al., andU.S. Pat. No. 4,955,911 to Frey et al.

There has been a gradual acceptance of interbody fusion as a procedurefor a number of spinal disorders. Interbody fusion procedures may employthe use of surgical mesh tubes, see for example “Chapter 10: TitaniumSurgical Mesh for Vertebral Defect Replacement and IntervertebralSpacers”, Gary L. Lowery and Jurgen Harms, Manual of Internal Fixationof the Spine, edited by John S. Thalgott and Max Aebi, Lippincoll-RavenPublishers, Philadelphia, 1996, which is incorporated herein byreference.

While devices for use in interbody fusion which comprise a mesh orporous material are known, there remains a long-felt need for a devicethat offers the advantages of conventional bone plates without theobstruction of mass transfer and tissue growth associated with certainprior art devices. For example, U.S. Pat. No. 7,651,497 to Michelson,which is hereby incorporated by reference in its entirety, disclosesvarious segmentable plates for application in reconstructive surgerieswhich may be contoured or shaped by a surgeon. Michelson, however, failsto disclose a device that is conformable to a surgical worksite and thatfurther facilitates bone and tissue regeneration within, through, orproximal to the device. The present invention contemplates variousfeatures and structures disclosed in Michelson which further comprisenovel features and aspects of the present invention as shown anddescribed herein.

One embodiment of the present invention comprises an array or series ofgenerally cylindrical components disposed on wires or a series ofelongate devices of pliable material and further bounded by a first andsecond anchor device or plate at the first and second longitudinal endsof the pliable material. First and second anchor devices comprise pointsof attachment for the wires or elongate devices and further provide forthe ability to anchor or secure the present invention to bone or aportion of the human anatomy. In one embodiment, the first and secondanchor device each comprise at least two through holes suitable foraccommodating a variety of surgical screws and similar fasteningdevices. In an alternative embodiment, the present invention comprises avariety of ports or apertures throughout the device wherein surgicalscrews or fastening/anchoring devices may be employed. For example, inaddition to or in lieu of anchor points which may be provided on thefirst and second anchor devices, anchor points may be provided atvarious locations interspersed between the generally cylindricalcomponents. In this embodiment, numerous anchor points are providedwhich allow for the device to be securely positioned in a variety oforientations. In one embodiment, prescribed eyelets or grommets areprovided at interstitial locations within an area defined by thegenerally cylindrical components. These eyelets may be comprised of avariety of materials, including, but not limited to, the groupconsisting of: surgical stainless steel, titanium, silicon, glass,quartz, plastic, metal and metal alloys, polymers, TiO, ZnO, ZnS, ZnSe,ZnTe, CdS, CdSe, CdTe, HgS, HgSe, HgTe, MgS, MgSe, MgTe, CaS, CaSe,CaTe, SrS, SrSe, SrTe, BaS, BaSe, BaTe, GaN, GaP, GaAs, GaSb, InN, InP,InAs, InSb, PbS, PbSe, PbTe, AlS, AlP, AlSb, SiO1, SiO2, siliconcarbide, silicon nitride, polyacrylonitrile (PAN), polyetherketone,polyetheretherketone (PEEK), polyimide, an aromatic polymer, and analiphatic polymer. Furthermore, eyelets or grommets provided in the areadefined by the generally cylindrical components, as well as throughholes provided on the first and second anchor devices, may be offset orangled to provide for a crossed configuration of bone screws and aresulting stable engagement of the device to a bone as further shown anddescribed in U.S. Pat. No. 7,651,497 to Michelson, which is herebyincorporated by reference in its entirety.

In one embodiment, the wires on which the generally cylindricalcomponents are disposed are substantially malleable or pliable to allowfor the present invention to be placed on, over, and/or generallyconform to a variety of non-planar surfaces and objects. Thus, in oneembodiment, the present invention provides for a surgical implant withimproved characteristics over currently known plating mechanisms in thatit is readily adaptable to various three-dimensional non-planarsurfaces, yet still provides for adequate rigidity and resistance toforces applied in tension, compression, and, to a certain degree,torsion. Furthermore, the present invention provides a device whichfosters growth, healing, and redevelopment of bone, tissue, and materiallocated beneath and proximal to the device. By providing a structurethat does not cover a target area in such a manner as to generallyprevent or prohibit substantial amounts of mass transfer (i.e. does notprevent the transfer of air, blood, and fluid), the present inventionfacilitates healing and repair of bone and other materials situatedbeneath and proximal to the present invention.

By providing a stacked arrangement of generally cylindrical components,one embodiment of the present invention provides the ability to resistcompression forces in one orientation, yet provides flexibility in anopposite (e.g. 90° orientation). While the present inventioncontemplates use in securing bone fracture sites, embodiments of thepresent invention may be utilized in procedures such as interbodyfusion, cage fixation, and spinal fixation. The present invention offersthe advantage of being able to at least partially conform to anon-planar work site in cage fixation procedures. The present inventionoffers such functionality while still providing sufficient resistance toforces applied in the z-axis.

The material used to construct the body of the present invention may bea non-porous material, such as surgical steel, titanium, or relatedalloys. In one embodiment, 316 stainless metal is utilized to formportions of the device, such as end plates, wires, and generallycylindrical components. In one embodiment, generally cylindricalcomponents are employed wherein the components are of approximately0.370 inch diameter and are approximately 0.500 inches in length. Wiresare preferably of a diameter between approximately 0.02 and 0.10 inches.In a preferred embodiment, wires are of a diameter between 0.03 and0.035 inches. In a more preferred embodiment, wires are of a diameter ofapproximately 0.033 inches. However, one of ordinary skill in the artwill recognize that the present invention is not bounded by thesedisclosed embodiments. Indeed, it is contemplated that the devicesemploying nanotechnology will comprise features of significantly smallerdimensions than these embodiments. Additionally, larger devices are alsocontemplated by the present invention and may be utilized, for example,in large non-human mammals or species.

In a preferred embodiment, the wires are securely welded to the endplates. However, one of skill in the art will recognize that the wiresmay be attached to the end plates in a variety of ways, so long asattachment is secure and there is minimal risk of the wires becomingdislodged from the plates before, during, or after implantation. In oneembodiment, metal parts of the present invention are malleable and nothardened.

In yet another embodiment, a single cylinder may have more than one wirepassing through its center, thus providing a way for adjacent columns ofcylinders to remain in desired proximity with each other. As one ofskill in the art will appreciate, different diameter sized cylinders canbe employed to form an overall expanse of columns and rows of cylindersstrung on wires so that a fabric appearance is achieved, but one notnecessarily uniform in every respect.

In one embodiment, metal surfaces (including but not limited to theinner surfaces of the cylinders) of the present invention are finishedin a satin finish to improve bone growth into the surface. In analternative embodiment, surfaces are roughened or unprocessed to enhancebone growth. For example, methods and devices as described in U.S.Patent Application Publication No. 2009/0292365 to Smith et al., whichis hereby incorporated by reference, may be utilized.

A plurality of openings may be provided on the surface of the presentinvention to enable mass transfer through the device. In one embodiment,openings are provided that allow the bone growth material to growthrough at least a portion of the present invention and fuse withvertebral members and other portions of the indigenous anatomy. Invarious embodiments, openings may be provided at regular intervals,organized in rows or columns, distributed radially, or staggeredrandomly. In one particular embodiment, openings consist of spatial gapsbetween generally cylindrical components and that are subject torepositioning and resizing based on a certain degree of freedom ofmovement of the generally cylindrical components with respect to eachother.

In one embodiment, the present invention ensures that bone-buildingmaterial will have osseous tissue growing through it from at least theside of the covering which faces the bone to achieve completeossification thereof and complete integration of the ingrown osseoustissue with the osseous tissue of the surrounding bone region.

In another embodiment, a member, which can have absorbable materialassociated therewith, acts to reinforce the healing site and is intendedto seat tightly against the bone on all sides. While the member can besecured to the bone, for example, by means of invasive fasteningelements, such as pins, which must traumatically engage the bone, in oneembodiment, avoidance of hammering the pins into the bone, whichtypically causes pain to the patient, can be alleviated by havingconnecting means that secures together two portions of the member so asto fit the member (e.g. bent around the bone), thus also avoiding theneed to ever subsequently remove pins, etc., after the bone has healed.Thus, in one embodiment, a flexible member has a surface that faces thebone and has two closure edges which permit the member to be wrappedaround the bone at the surgery site and to be firmly closed in theregion of the surgery site by means of connector elements.

Therefore, the present invention contemplates an appliance for coveringa surgery site of a bone in vivo, comprising a flexible member adaptedfor contacting the bone surface of a patient to promote healing of abone surface. In one embodiment, the member has a first side and asecond side, the first side being adapted to face toward said bone, andthe second side adapted to face away from said bone. The member has atleast two closure edges proximate each other when said member is wrappedaround bone. Furthermore, connecting means are provided, engaging the atleast two closure edges, for connecting said closure edges to firmlyhold the member around the bone.

In a particular embodiment, the present invention comprises a surgicalimplant adapted for use with the human wrist. For example, an implant isprovided which is adapted to cover or be applied to at least a portionof the circumference of a human wrist (i.e. the combined circumferenceof the radius and ulna). In one embodiment, the implant allows for atleast some degree of natural rotation of the wrist bones about alongitudinal axis of the forearm, while simultaneously provided adequatesupport for the wrist and resistance to, for example, moment forces thatmay be applied to the wrist and/or forearm. Additionally, the deviceprovides various additional benefits of the present invention whereinthe device is readily conformable to a variety of shapes/topography andfurther allows for the exchange of air and fluid through the device,thereby promoting healing and regenerative functions.

In one embodiment, the present invention comprises an implant thatprovides the same or similar structural support to a bone plate as usedin connection with a wrist, yet further allows for natural rotation ofvarious features of the wrist as well as promoting healing, bone, andtissue growth in one or more areas directly beneath the device.

In one embodiment, the present invention comprises a non-surgical braceor device that is worn externally on a patient. For example, variousfeatures of the present invention may be incorporated within or used toform an externally-worn wrist support which prevents or minimizedunwanted bending without overly prohibiting rotational movement of awrist and components thereof.

The present invention, in one embodiment, comprises an implant forsurgical use in humans or vertebrates, in particular for thereplacement, for the partial replacement or for the strengthening of adamaged intervertebral disk or for the replacement, for the partialreplacement or for the strengthening of an anatomical joint.

Such an implant should essentially correspond to the dimensions and theshape of the joint to be replaced or of the intervertebral disk to bereplaced, have adequate biocompatibility with the surrounding tissue andespecially comparable physical properties, in particular with respect torigidity, elasticity, resilience and damping, and make possibleunrestricted movement within the course of natural movement and have along lifetime in order not to stress a patient by frequent implantchanges.

To promote bone ingrowth into the implant, the outsides of the implantsoriented toward the bone are preferably provided with a surfacestructuring. In one embodiment, the surface structuring comprises avariety of recesses. The recesses may be formed by providing generallycircular grommets and/or by providing a stacked arrangement of generallycylindrical components with interstitial spaces therebetween.

In preferred embodiments of the present invention the device is able tobe adapted, by a simple variation of wire and/or cylinder composition,spacing, size, etc. to affect its rigidity, elasticity and itsresilience and internal damping, to conform to the desiredcharacteristics or specifications of the corresponding joint orintervertebral disk to be replaced or to be supported.

Owing to internal friction of the wires and generally circular members,oscillations are effectively damped, such as are initiated from outsideon the body system, intervertebral disk and/or joints by walking,running and especially by jumping. The fabric formed by the abovedescribed wire and generally circular member configuration is reliablygreatly deformable yet supportive, a combination greatly desired forparticular applications in bone surgery.

Materials which can be used to construct suitable embodiments are, inparticular, alloys which contain, inter alia, as constituents in variousquantitative proportions, titanium, cobalt, chromium, aluminum,vanadium, niobium and/or zirconium or stable plastics, as well asresorbable organic materials, in this case, inter alia, catgut, catgutchromium or collagen or else alternatively resorbable syntheticmaterials, such as organically degradable polymers, in this case, interalia, Vicryl, Polysorb, Dexon, Piralac, Serafit, Bondek, Maxon orPanacryl.

The elasticity and damping and all other parameters (e.g. dimensions)are chosen according to the natural implants to be replaced.

In one embodiment, the device has the ability to adjust to the stressesdue to elastic or plastic deformations without lasting damage owing toits flexibility and is insensitive to tilting and bending and imparts tothe human or the vertebrate the ability to carry out bending, tiltingand rotation and translation movements.

In certain embodiments, the implants may substantially be anatomicallyshaped, i.e. the dimensions and the shape of the implant shouldcorrespond essentially to the dimensions and the shape of theintervertebral disk to be replaced and/or of the anatomical joint to bereplaced. However, for reasons of functionality in the production and inthe incorporation of the implant it can also be advantageous undercertain circumstances to choose another shape.

Under certain circumstances, the use of a material resorbable by thebody can be useful in conjunction with various embodiments describedherein. This is provided in the particularly advantageous embodiment inwhich the implant is colonized with stem cells or with endogenous cellswhich are cultured in the laboratory. The great advantage here is thatthe new implant connects strongly with the bone, while, for example,implants of plastic or other materials loosen with time and/or can leadto foreign body reactions. Here, the fabric foaming the implant servesas a support structure. The fabric can comprise one or more of saidresorbable materials and/or one or more of said biocompatible materials,in particular titanium, which then remains permanently in the body as asupport structure.

The wire diameter and/or the dimensions of the generally circularmembers are chosen here in order to make possible a simple in-growth ofthe stem cells or of the endogenous cells.

The individual parameters may be determined empirically, such as byselecting: wire composition, length, flexibility, gauge, cylinderdimensions, composition, size relative to adjacent cylinders, etc. Thusthe properties of the shaped article to be formed or of the implant tobe formed on the properties of the intervertebral disk to be replaced orof the joint to be replaced can be optimally adjusted so that theimplant optimally handles the local stress in its function and makespossible an improved transfer of force from the implant to the bone.

In one embodiment, the present invention comprises a generallynon-flexible member. For example, an embodiment is contemplated wherethe stacked arrangement of generally cylindrical components is disposedon a series of parallel wires, yet is of a generally fixed shape. Such afixed shape may include, for example, a flat plate or a device with aU-shaped cross-section. In this embodiment, the device may compriseenough flexibility to be spread or placed around a bone, but isgenerally not conformable to a shape substantially different from itsoriginal shape and position.

In one embodiment, a mesh system incorporating the fabric constructiondescribed herein comprises a general use skeletal mesh having a bottomsurface for placement against bone portions, wherein a substantialportion of the bottom surface of the mesh is either flat or convex alongthe longitudinal axis of the mesh. It is appreciated that a lesserportion of the lower surface of the mesh may be otherwise shaped. Themesh of the present invention has a plurality of bone screw receivingholes which extend through the mesh, from the upper surface to the lowersurface. The mesh and its component parts may be made of any implantquality material suitable for this purpose and suitable for use in thehuman body, such as, but not limited to, titanium or its alloys. Themesh and/or the associated components may be made of a bioresorbablematerial and may comprise or be coated at least in part with fusionpromoting chemical substances, such as bone morphogenetic proteins andthe like.

Bone screws are each insertable into a respective bone screw receivinghole for attaching embodiments of the present invention to bone. Alocking element, preferably, but not necessarily, in the form of ascrew, is engageable in the locking screw hole of the present inventionand has a head formed to lock at least two of the bone screws to thepresent invention. In the preferred embodiment, the locking elements arepre-installed prior to use by the surgeon in a manner so as to notimpede installation of the bone screws into the bone screw receivingholes.

Employing, for example, the breathable, supportive, yet flexibleband-aide structure described herein, the problems previously associatedwith locking screws of the type applied after the insertion of the bonescrews, including the problems of instrumentation to position anddeliver to the mesh the locking means, backing out, breakage, strippingand misthreading associated with the prior art more delicate lockingscrews resembling “watchmaker's parts,” are substantially reduced and/oreliminated.

In a further embodiment of the present invention, a segmentable meshsystem is disclosed combinable with the multiple lock and single-lockmesh system and the crossing screw teaching, as well as combinable withother novel features herein disclosed. The segmentable mesh systemprovides a single mesh, or a limited set of mesh, for aligning andmaintaining bone portions in selected spatial relationship in which themesh are manufactured so as to be strong in use, but separable intoshorter lengths by the surgeon as needed, thereby eliminating the needto stock a multitude of mesh lengths.

In one embodiment, the present invention comprises cylinders that are atleast partially adapted to receive one another. For example, in oneembodiment, a first end of a cylinder comprises an open aperture whichis generally circular when viewed in cross-section and a second end ofthe cylinder comprises a generally frustoconical nose portion which isadapted to fit within the first end of another cylinder. Thus, cylindersare adapted to fit at least partially within one another, providing forsmoother bending/flexing of the device. In another embodiment, cylindersare adapted to receive at least a certain segment of another cylindersuch that there is a slight telescoping or nesting of stacked cylinders.Thus, two cylinders on a single wire may translate within and withrespect to one another (e.g. when a patient bends or stretches), butwithout complete disengagement of the cylinders.

According to one embodiment, an implant is provided with a textured boneand soft-tissue attachment surface that includes an implantable bodyhaving a micro-textured soft tissue ongrowth attachment surface thereon.The micro-textured surface is a roughened surface texture covering themacro-texturing for optimizing soft tissue ongrowth.

By way of example, for application in the spine, an embodiment of thesegmentable mesh system of the present invention comprises a mesh thatis capable of spanning multiple segments of a cervical spine and haspredetermined separation zones.

The separation zones may be positioned in a segmentable mesh such thatwhen a portion of the segmentable mesh would be applied to thevertebrae, the remaining separation zones in the mesh, if any, would besupported by an underlying vertebra. In use, the surgeon would determinethe appropriate mesh length needed and if the length needed was lessthan the length of the provided mesh, the surgeon would remove theunneeded portion of the mesh at the appropriate separation zone. By wayof example, this procedure may be easily performed when the mesh is madeof titanium or one of its alloys, as the properties of titanium are suchthat when the mesh is bent and then returned to its original position, aclean separation is made at the bend. The parts of the segmentable meshthat are being separated can be held to either side of the separationzone to ensure that a precise separation is effected. The separationzones of the segmentable mesh, by way of example, may comprise the meshbeing scored along its upper, lower, or both upper and lower surfaces.The depth of such scores being dependent on the thickness of the mesh,and being sufficient to create surface notchings and a path of leastresistance for the mesh separation, and yet of limited depth and shape,so as to not weaken the mesh so as to render it less than sufficientlystrong for its intended use. It will be understood that reference to“mesh” is intended to include at least structures as depicted in theFigures and otherwise described herein, but is not necessarily to beconstrued as being so limited. For example, mesh-type structures knownthe prior art may be employed in concert with particular wire and/orcylinder constructs.

By way of example, for application to the anterior aspect of thecervical spine four segmentable mesh each having generally a similarlength (for example sufficient to span five vertebrae, a length of from80 to 120 mm), and each having different spacing between pairs of bonescrew holes, could comprise a complete set of mesh allowing a surgeon tohave all lengths and hole spacing needed to fuse from two to fivevertebrae. While the described mesh may be separable into a multitude ofusable portions, because of regulatory issues involving theidentification of each implant with a distinct and singular implantidentification number for tracking purposes. It may be desirable toconfigure the mesh of the present invention such that each mesh willyield only one usable portion.

The segmentable mesh system of the present invention also hasapplication in reconstructive surgery. For example, during repair of abroken eye socket, the segmentable mesh system of the present inventioncan be used to align and maintain the broken bone portions in correctspatial relationship. The curved characteristic of an eye socketrequires that the mesh used to repair the socket will match thecurvature. The parallel wires of the present invention may be made of amalleable and/or flexible metal, such that it can more easily becontoured by the surgeon to the appropriate curvature. The 90°orientation of cylinders presents a structure capable of supportingtissue and bone. The ability to provide discrete, inter-lockablesegments also provides significant advantages.

Therefore, while various mesh implants are known, they fail to disclosea number of novel features of the present invention. For example, U.S.Pat. No. 5,766,176 to Duncan discloses a formable mesh for use inosteosynthesis. Duncan fails to teach, however, a device suitable foruse in spinal procedures which generally conforms to non-planar surfaceswhile still providing sufficient resistant to force in variousdirections.

In one aspect of the invention, a medical device is disclosed comprisinga body structure having one or more surfaces having a plurality ofnanostructured components associated therewith, such components similarto those depicted in the Figures. Such medical devices may comprise animplantable device, intracorporeal or extracorporeal device, a temporaryor permanent implant, a stent, a vascular graft, an anastomotic device,an aneurysm repair device, an embolic device, a catheter, valve or otherdevice which would benefit from a structured surface according to theteachings of the present invention. The plurality of nanostructuredcomponents may comprise, for example, a plurality of nanofibers ornanowires, as well as nano-scale cylinders positioned on suchwires/fibres. The plurality of nanostructured components enhance one ormore of adhesion, non-adhesion, friction, patency or biointegration ofthe device with one or more tissue surfaces of a body of a patientdepending on the particular application of the device. The nanofibers(or other nanostructured components) on the surfaces of the medicaldevice can optionally be embedded in a slowly-soluble biocompatiblepolymer (or other) matrix to make the nanofiber surfaces more robust.The polymer matrix can protect most of the length of each nanofiber,leaving only the ends susceptible to damage. The generation of watersoluble polymers can be accomplished in a number of different ways. Forexample, polymer chains can be formed in situ in a dilute aqueoussolution primarily consisting of a monomer and an oxidizing agent. Inthis case, the polymer is actually created in the solution andsubsequently spontaneously adsorbed onto the nanofiber surfaces as auniform, ultra-thin film of between approximately 10 to greater than 250angstroms in thickness, more preferably between 10 and 100 angstroms.

The plurality of nanofibers or nanowires may comprise an average length,for example, of from about 1 micron to at least about 500 microns, fromabout 5 microns to at least about 150 microns, from about 10 microns toat least about 125 microns, or from about 50 microns to at least about100 microns. The plurality of nanofibers or nanowires may comprise anaverage diameter, for example, of from about 5 nm to at least about 1micron, from about 5 nm to at least about 500 nm, from about 20 nm to atleast about 250 nm, from about 20 nm to at least about 200 nm, fromabout 40 nm to at least about 200 nm, from about 50 nm to at least about150 nm, or from about 75 nm to at least about 100 nm. The plurality ofnanofibers or nanowires may comprise an average density on the one ormore surfaces of the medical device, for example, of from about 0.11nanofibers per square micron to at least about 1000 nanofibers persquare micron, from about 1 nanofiber per square micron to at leastabout 500 nanofibers per square micron, from about 10 nanofibers persquare micron to at least about 250 nanofibers per square micron, orfrom about 50 nanofibers per square micron to at least about 100nanofibers per square micron. The plurality of nanofibers or nanowiresmay comprise a material independently selected from the group consistingof: silicon, glass, quartz, plastic, metal and metal alloys, polymers,TiO, ZnO, ZnS, ZnSe, ZnTe, CdS, CdSe, CdTe, HgS, HgSe, HgTe, MgS, MgSe,MgTe, CaS, CaSe, CaTe, SrS, SrSe, SrTe, BaS, BaSe, BaTe, GaN, GaP, GaAs,GaSb, InN, InP, InAs, InSb, PbS, PbSe, PbTe, AlS, AlP, AlSb, SiO1, SiO2,silicon carbide, silicon nitride, polyacrylonitrile (PAN),polyetherketone, polyimide, an aromatic polymer, and an aliphaticpolymer.

The nanofibers or nanowires may be attached to the one or more surfacesof the body structure of the medical device by growing the nanofibers ornanowires directly on the one or more surfaces, or the nanofibers orwires may be attached to the one or more surfaces of the body structureby attaching (e.g., via a covalent linkage) the nanofibers or nanowiresto the one or more surfaces using one or more functional moieties, forexample. The body structure of the medical device may be made from avariety of materials, and the plurality of nanostructured components mayoptionally be incorporated into the material(s) of the body structure.The nanofibers (or other nanomaterial) may be stiffened by sintering thefibers together (or otherwise cross-linking the fibers, e.g., bychemical means) prior to incorporating the nanofibers into the materialof the body structure to provide enhanced rigidity and strength. Themedical device may further comprise one or more biologically compatibleor bioactive coatings applied to the one or more nanostructuredsurfaces, and/or the nanofibers or nanowires may be incorporated into amatrix material (e.g., a polymer material) to provide greater durabilityfor the fibers or wires.

One aspect of certain embodiments of the present invention is directedto systems and methods for spinal stabilization and fixation, useful inthe replacement, reconstruction or augmentation of spinal ligament orbony tissues, and also in alternatively resisting or facilitatingcertain tensile and rotational loading applied thereto by spinal motion.As described herein, the particular varied configurations of embodimentscomprise filaments or wires surrounded by generally freely rotatablecylinders (although other shapes, including polygonal structures havingvarious flat or curved faces may be employed in addition to and/or inlieu of cylinders). Each individual filament/wire contains at leastthree, more preferably at least about five, and even more preferably atleast about ten cylinders. Such filaments/wires are positioned in agenerally parallel fashion with respect to each other. The respectivelyadjacent wires with associated hollow centered cylinders that are strungthereon are provided in desired proximity to a similar wire havingsimilar cylinders. The particular lengths of each given cylinder can bethe same or different as the particular overall desired structuralcharacteristics dictate. For example, generally the smaller length ofsequential cylinders will provide more flexible characteristics to anoverall structure. Differently composed cylinders can be provided on asingle wire or on separate wires to achieve certain desirable overallcharacteristics of the structure. For example, PEEK cylinders can beemployed for certain flexibility advantages as compared to steel ortitanium cylinders. If an entire row or column of cylinders (e.g. eitherstrung on a single wire or adjacent to one another but on differentadjacent wires) is composed of a similar material (such as a row of PEEKcylinders in a larger composite structure of steel wires/cylinders, thusresembling a fabric), then one can achieve desired points of increasedor decreased flexibility to advance desired spinal motion in a patientinto which such a structure is implanted. Due to the relativeflexibility of the filament/wire, the structure is able to bend or flexfar more in one direction than in a direction 90 degrees from suchdirection. Indeed, in a direction whereby the cylinders are stacked withtheir flat edges (e.g. top of cylinders facing each other) the structuredemonstrates considerable load supporting capacity in such direction,while simultaneously being able to be twisted in a different plane, aswell as bent or flexed in still another plane. For example, such astructure is able to be twisted in a fashion such that certainadvantageous dynamic flexion is permitted, which is at least partiallyachieved by freely rotatable cylinders (although other shapes, includingpolygonal structures having various flat or curved faces). Thus, in oneembodiment, the present invention comprises a device with a combinationof flexibility in certain respects, and also certain stability, loadbearing and rigidity in other respects (e.g. along distinct planes ofmovement).

In one form, an elongated implant comprising the above describedstructure is configured to span the intervertebral disc space with itsends attached to a respective vertebral body. The implant can have asubstantially flexible yet substantially inelastic body with a lowprofile capable of conforming to the spinal anatomy. The anchors used toattach the ends of the implant to the vertebrae can be at leastpartially concealed in the vertebral body to which it is engaged,further reducing the profile of the device. Examples of suitable anchorsinclude interference screws, suture anchors, bone screws, buttons, pinfasteners, and staples. It is further contemplated that the implant andanchors can be made from nonresorbable or resorbable material.

In one technique, the stabilization system can be attached to andstabilize the anterior portion of the spinal column. The stabilizationsystem can also be attached to and stabilize the lateral oranterior-lateral portion of the spinal column. In another technique, thestabilization system is attached to a posterior portion of the spinalcolumn via anchors engaged to the vertebrae at any one of a number oflocations, including but not limited to the facets, pedicles, pars,transverse processes, or spinous processes. Preferred attachmenttechniques provide a low profile system that reduces exposure andcontact with the adjacent anatomic structures.

Although one embodiment contemplates freely rotatable cylinders, variousother shapes, including polygonal structures having various flat and/orcurved faces and surfaces may be employed in the present invention.Additionally, weight and resorbability may be enhanced withoutsignificantly degrading the structural integrity of cylinders or similardevices by providing holes, knurling, or aeration in the cylinders orsimilar devices. Such devices are within the scope and spirit of thepresent invention.

The present invention is particularly useful for augmenting single ormulti-level anterior interbody fusions. In some embodiments, the systemis designed for use in the anterior lumbar region of the spine, and sois characterized by relatively larger ligament lengths (between 20 mmand 30 mm) in order to span the disc space. In other embodiments, thesystem is designed for use in the cervical region of the spine, and sois characterized by ligaments having relatively small lengths (such asbetween 12 mm and 15 mm) and small thickness (such as between 0.5 mm andless than 2 mm) in order to avoid exposure to the esophagus.

Generally, the bone fasteners of the present invention may be fastenedto any portion of the anterior, lateral or posterior surface of thevertebral body. Preferably, however, the bone fasteners are fastened tothe anterior surface in order to take advantage of the low profileproduced by the system and to avoid a second surgery (posterior) inanterior interbody fusion procedures. In one embodiment, a“shoulderless” bone fastener may be employed that has no shouldercapable of seating upon the vertebral surface in a degree sufficient toprevent further driving of the bone fastener into the vertebral body.

Various embodiments of the present invention, including for example,ligament aspects hereof, may be coated or embedded with one or morebiologically or pharmaceutically active compounds such as cytokines(e.g., lymphokines, chemokines, etc.), attachment factors, genes,peptides, proteins, nucleotides, carbohydrates, cells or drugs.

In a preferred embodiment, bone fasteners are positioned in closeproximity to the vertical portion of the endplate portions of thevertebral bodies to achieve a more secure fixation of the system due tothe relatively higher hardness of the endplate region. Bone fasteners ofthe present invention may be fastened to the superior or inferiorportions of the vertebral bodies near their endplates in the transitionzone between the cortical and cancellous bone regions, preferably insome embodiments associated with a disk prosthesis component suitable asa replacement for a particular natural disk with an intervertebralconnection system having a ligament whose length is designed forinsertion of the bone fasteners into the endplates adjacent that naturaldisk.

In one embodiment, a surgical implant for strengthening a bone or jointis provided, the implant comprising a plurality of individual parallelspaced wires extending from and affixed to a first anchor member and asecond anchor member. Each individual parallel spaced wire has aplurality of generally circular members surrounding it, the generallycircular members being freely rotatable about a single one of the wires.

In another embodiment, an implant is provided with a plurality of wiresand a plurality of generally circular members which form a fabric-likestructure that permits liquids to flow therethrough and permits boneingrowth when implanted adjacent to a patient's bone.

The plurality of wires and plurality of generally circular members maycomprise at least one biocompatible material selected from the groupconsisting of ceramic, PEEK, titanium, stainless steel, stainless steelalloys and titanium alloys. In one embodiment, the implant comprises aplurality of wires and a plurality of generally circular memberscomprising a resorbable synthetic material.

In various embodiments, the implant has a plurality of wires with adiameter approximately between 0.01 mm and 2 mm and a lengthapproximately between 0.060 inches and 0.500 inches.

In various embodiments, the implant has a plurality of wires comprisingone of ceramic, titanium, stainless steel, stainless steel alloys andtitanium alloys and PEEK.

In one embodiment, a device for covering a surgery site of a bone invivo is provided, the device comprising a plurality of elongate flexiblemembers having a first end, a second end, and a longitudinal axistherebetween. The longitudinal axis comprises a length that issignificantly larger than a thickness of the elongate flexible member. Aplurality of generally cylindrical members is disposed on each of theplurality of elongate flexible members, the cylindrical memberscomprising a hollow interior portion such that a portion of thelongitudinal axis of one of the elongate flexible is allowed to passand/or be threaded therethrough. The plurality of elongate flexiblemembers and the plurality of generally cylindrical members form astructure that permits liquids (e.g. bodily fluids) to flow therethroughand permits bone growth when implanted adjacent to a bone. Additionally,the device has at least two predetermined locations for receiving afastener for anchoring the device in a specific location.

The first ends of the elongate flexible members are secured to a firstanchor plate and the second ends of the elongate flexible members aresecured to a second anchor plate, the first and second anchor platescomprising an aperture for receiving a bone screw or similar fasteningdevice.

The device may be further provided with at least two closure edgesproximate each other when the device is wrapped around a bone andconnecting means for engaging said at least two closure edges to firmlyhold said member around said bone.

These and other needs are addressed by the various embodiments andconfigurations of the present invention. These and other advantages willbe apparent from the disclosure of the invention(s) contained herein.The above-described embodiments, objectives, and configurations areneither complete nor exhaustive. As will be appreciated, otherembodiments of the invention are possible using, alone or incombination, one or more of the features set forth above or described indetail below.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a top plan view of one embodiment of the present invention;

FIG. 2 is a top plan view of one embodiment of the present invention;

FIG. 3 is an isometric view of one embodiment of the present invention;

FIG. 4 is an isometric view of one embodiment of the present invention;

FIG. 5 is an elevation view of one embodiment of the present invention;

FIG. 6 is an elevation view of one embodiment of the present invention;

FIG. 7 is an isometric view of one embodiment of the present invention;

FIG. 8 is an elevation view of one embodiment of the present invention;

FIG. 9 is an elevation view of one embodiment of the present invention;

FIG. 10 is a side elevation view of one embodiment of the presentinvention;

The drawings are not necessarily to scale.

DETAILED DESCRIPTION OF THE FIGURES

FIG. 1 depicts one embodiment representative of the present invention200, wherein stacked or arranged components of generally cylindricalconstruction are provided. Anchor plates 250 are provided and furtherequipped with through holes 254 which can accommodate any number ofknown surgical screws or acceptable fixation devices (not shown, but 199in FIG. 2). Anchor plates may be comprised of a variety of knownsurgical grade metals, including but not limited to surgical steel,titanium and titanium alloys. In addition to providing means foranchoring the present invention 200 to a bone or surgical area, anchorplates 250 define the terminal boundaries of wires 258 disposed betweenthe anchor plates 250. In one embodiment, wires 258 are of sufficientstrength to resist tension forces that may be applied, but are of a thinenough gauges to allow for manipulation and shaping of the device byhand. Wires 258 may be comprised of a variety of known surgical grademetals, including but not limited to surgical steel, titanium andtitanium alloys. Disposed on the wires 258 is an array of generallycylindrical elements 262 which are generally free to rotate about anaxis corresponding to the longitudinal axis of the wires 258. Althoughtwelve stacked cylindrical components 262 are shown in FIG. 1, one ofskill in the art will recognize that any number of these components 262may be provided, either by selecting different sized cylindricalcomponents 262 and/or by varying the dimensions of the device 200.

As shown and described, a stacked or threaded arrangement betweenelements 262 and wires 258 is provided. As used herein, threaded doesnot necessarily refer to a threaded member such as a screw or threadedhole, but more generally refers to an arrangement whereby at least aportion or length of one object (e.g. wire 258) extends through at leasta portion of another object (e.g. element 262).

The stacked arrangement allows for a device which is capable ofproviding sufficient resistance to forces applied in the x-axis (i.e.tension and/or compression) as well as forces which may be applied inthe z-axis (i.e. out of the page with respect to FIG. 1). However, theflexibility of the wires 258, the arrangement of the generallycylindrical components 262, and spacing which may be provided betweenthe cylindrical components 262, allow for a user to mold or shape thedevice 200 to conform to a variety of anatomical features and surgicalsites. In one embodiment, the device 200 is capable of being molded orre-shaped manually by a surgeon in operating room conditions. Thus, inone embodiment, the device 200 provides for a band-aid like surgicalimplant which functions similarly to conventional plates in some aspects(i.e. comprises the ability to resist certain forces) yet is readilyconformable to a variety of shapes/topography and further allows for theexchange of air and fluid through the device 200.

FIG. 2 depicts another embodiment of the present invention 200, where aplurality of apertures, eyelets, or grommets 220 are provided within aspace defined by the generally cylindrical components 262. FIG. 2displays one embodiment of the present invention wherein numerouscylindrical components 262 are provided. One of skill in the art willrecognize that the present invention is not limited to any particularsize or number of generally cylindrical components 262. The size andquantity of these components 262 may vary according to size of thepatient, area in which the device 200 is to be applied, etc.

Grommets 220 provide for points of attachment for surgical screws 199and further facilitate the conformity of the device 200 to variousnon-planar regions. One of skill in the art will recognize that anynumber of these grommets 220 may be used (i.e. provided with a pin,screw or anchor) or left unutilized. Where grommets 220 are providedwhich are not used, it will be recognized that these unused grommets 220constitute empty spaces which further facilitate mass transfer throughthe device. Thus, in one embodiment, no further action need to be takenwhere the grommets 220 are not used. In an alternative embodiment, plugsor fillers (not shown) may be disposed within undesired grommets 220.Such plugs may be comprised of a material that is compatible with thematerial comprising the implant 200.

FIG. 2 further includes a call-out illustrating how grommets 220 may beincorporated into the wire 258/cylinder 262 network of the presentinvention. As will be recognized, grommets 220 must comprise more than amere hole formed through a fabric or woven network. Thus, grommets 220are provided which provide for points of attachment with wires 258.

FIG. 3 depicts one embodiment of the present invention where a spinalrod is modified and comprises generally cylindrical components of thepresent invention. For example, cylindrical components 262 may comprisea portion of the device intended to interface with bone. Providing thesecomponents 262 in at least portions of such a device offers advantagesof being improved bone growth within and around aspects of the device.Although FIG. 3 is shown with features of the present inventionincorporated into a rod fixation system, it will be recognized thatthese features may be incorporated into a variety of surgical implantswhere it is necessary or desirable to allow for increased bone andtissue growth underneath an implant or an area immediately surroundingan implant.

FIG. 4 depicts an embodiment of the present invention wherein portionsof a spinal implant cage 300 comprise generally cylindrical components262 and allows for bone growth and osteosynthesis through at least aportion of the cage. For example, surfaces 304, 308 of a spinal implantcage may be comprised of an array of generally cylindrical components262 to allow for bone growth and/or resorbtion through these portions304, 308. Where generally cylindrical components 262 disposed on wires258 are to be implemented in a portion of a device 316 that spans adistance, the device and array of cylindrical components 262 may need towithstand certain amounts of forces applied in bending or moment. Thoseof ordinary skill in the art will recognize that varying the thicknessand/or gauge of the wires 258 employed will allow for the device toaccommodate smaller or larger amounts of bending moment. Those of skillin the art will recognize that both portions 304, 308 of a spinalimplant cage need not comprise the same size, number, or arrangement ofgenerally cylindrical components 262. Indeed, a cage with a differentcomposition of generally cylindrical components 262 on a top 304 andbottom 308 portion of is contemplated as within the scope of the presentinvention.

As further shown in FIG. 4, sidewall portions 320 of a spinal implantcage may also be comprised at least partially of a stacked arrangementof generally cylindrical components 262. Sidewall portions 320 of animplantable cage may further comprise apertures 312 through which screwsmay be placed or which simply allow for transmission of certain fluids,or both. In one embodiment, when cylindrical components 262 are stackedto form portions of a sidewall 320, the cylinders 262 may be oriented sothat their longitudinal axis is generally perpendicular with alongitudinal axis of a human spine (not shown) in which the implant isto be placed. Thus, when compression forces are applied due to gravity,activity, or general load bearing on the spine, the stacked arrangementis capable of accommodating compression forces. It will be recognizedthat the buckle strength of such an arrangement will be dependent upon anumber of factors, including, for example, strength of the cylinders,length of the cylinders, overall height of the implant, spacing betweenwires 258, gauge and strength of the wires, material properties, andother factors. Thus, the dimensions and characteristics of the cage maybe tailored by altering these factors as will be apparent to one ofskill in the art for the size and type of patient in which such a cageor similar device will be utilized.

Generally cylindrical components as shown in FIG. 4 and as will berecognized by those of skill in the art may be bounded by any number offeatures. For example, cylinders 262 may be bounded and generally heldin position by end plates as described herein or by any number of othersimilar devices. Cylinders 262 may be bounded by, for example, main bodyportions of an implantable cage which define the maximum longitudinaldistance with which a cylinder can travel.

FIG. 5 depicts a possible application of the present invention 200 to anon-planar implant site. As shown, a bone 400 to which variousembodiments of the present invention may be applied is not necessarilyflat or planar. Aspects of the present invention, including malleable orflexible wires (not shown) and corresponding generally cylindricalcomponents are provided which allow for the present invention 200 to bemanipulated by a user and conform to a variety of different surfaces. Amain portion of the device 200 is provided that further allows for thetransfer of mass, such as blood, fluid, and air, to and from anunderlying portion of the bone 300 to be repaired. It will be recognizedthat the present invention may be applied to such a non-planar site 400in a variety of orientations. For example, in FIG. 5, the implant may beapplied with rollers 262 disposed so that a longitudinal axis of therollers 262 is perpendicular to a longitudinal axis of the bone 400.Alternatively, the invention may be applied with a longitudinal axis ofthe rollers 262 being parallel to a longitudinal axis of the bone 400and wrapped around at least a portion of the circumference of a bone400. It will further be recognized that size and quantity of rollers262, as well as the dimensions and properties of the wires 258 may beadjusted so as to achieve the most appropriate fit to the workspace.

FIG. 6 depicts one embodiment of the present invention wrapped or drawnaround a surgical work site. As shown, embodiments of the presentinvention may be wrapped around the circumference of a bone 404 tosecure, for example, a fracture site while still allowing for masstransfer to the bone 404. Although FIG. 6 shows this aspect of thepresent invention with respect to fracture-type application, the presentinvention contemplates various other uses of such a device, including,but not limited to, applications in spinal fixation procedures.

FIG. 7 is an isometric view of one embodiment of the present invention,showing cylinders 262, wires 258, through holes 254 and end plates 250.The drawing is not necessarily to scale and various dimensions of theembodiment shown in FIG. 7 may be altered, adjusted, and modified basedupon specific needs and desired uses of the invention. The presentinvention offers numerous advantages of known braided mesh devices.Particularly, the stacked arrangement contemplated by the presentinvention allows for the accommodation of greater forces and reducedrisks of separation or failure while still providing a device that iscapable of conforming to a variety of non-planar surfaces. Thus,non-braided embodiments of the present as shown and described hereinoffer advantages to both patients and surgeons.

FIGS. 8-10 show one embodiment of the present invention for use inspinal fusion procedures. Spinal fusion typically requires posteriorfixation devices to achieve stability and rigidity. However, in theseprocedures, it is often advantageous to utilize low-profile devices forposterior fixation (and similar procedures) which are furthermorebiocompatible and foster growth and development of bone and tissuedisposed beneath and/or proximal to the device. Thus, devices as shownand described herein may be utilized to provide a generally conformabledevice for use in spinal fusion procedures. Furthermore, in oneembodiment, these devices comprise shoulderless attachment featureswhich allow for devices of the present invention, such as bone screws orpins, to be fully driven into the vertebral surfaces. Thus, low-profilesecure attachment is achieved in spine stabilization procedures.Attachment devices and locations may reside within an area defined bygenerally cylindrical components of the present invention, and/or mayreside within endplates or various extensions of the present invention.

FIG. 10 depicts a side elevation view of one embodiment of the presentinvention showing various a dynamic implants anchored to a spine at aplurality of locations. Anchoring devices and apertures for receivinganchoring devices may be provided as shown and described in the presentdisclosure. For example, apertures or grommets may be provided atpredetermined locations which correspond to vertebral spacing (i.e. fora given patient size and/or location along the spine) or may be providedat a variety of locations on the device. In one embodiment, a pluralityof such grommets is provided which may be utilized or disregarded at auser's discretion.

While various embodiments of the present invention have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present invention, as set forth in theSummary, Detailed Description, and in the following claims. Further, theinvention(s) described herein are capable of other embodiments and ofbeing practiced or of being carried out in various ways. In addition, itis to be understood that the phraseology and terminology used herein isfor the purposes of description and should not be regarded as limiting.The use of “including,” “comprising,” or “adding” and variations thereofherein are meant to encompass the items listed thereafter andequivalents thereof, as well as, additional items.

What is claimed is:
 1. A surgical implant device comprising: a pluralityof elongate wire members having first and second ends, said membersspaced generally parallel to each other to form adjacent rows; aplurality of generally uniformly shaped members threaded on saidplurality of elongate wire members, wherein a first member has a flattop end and a flat bottom end, and has a first elongate wire memberthreaded therethrough, and a second member has a flat top end and a flatbottom end and has a second elongate wire member threaded therethrough,said bottom end of said first member being in contact with said top endof said second member, wherein said plurality of elongate wire membersand plurality of generally uniformly shaped members form a malleablemesh-like surface structure that permits liquids to flow threrethrough,said plurality of elongate wire members being spaced parallel to eachother and extending from and affixed to a first anchor plate and asecond anchor plate, said plurality of generally uniformly shapedmembers being rotatable about said wires, and being in a stackedarrangement where said flat bottom end of said second member contactssaid flat top end of said first generally uniformly shaped member, andwherein said generally uniformly shaped members resist compressionforces in a first orientation and provides flexibility in an a secondorientation that is 90° from said first orientation, said firstorientation extending along an axis parallel to the plurality ofelongate wire members.
 2. The device of claim 1, wherein the arcuatemembers are cylindrical.
 3. The device of claim 1, wherein each of saidplurality of arcuate members has a hollow interior portion through whichat least one of said plurality of elongate wire members passestherethrough.
 4. The device of claim 1, wherein said device permitsnatural rotation of a person's wrist when said plurality of elongatewire members are aligned with a longitudinal axis of a patient's wrist.5. The device of claim 1, wherein the generally uniformly shaped membersare made of a material selected from the group consisting of titanium,titanium alloys, cobalt-chrome alloys, stainless steel and PEEK.
 6. Thedevice of claim 1, wherein said plurality of elongate wire members havea diameter of approximately between 0.010 mm and 2.00mm, a length of atleast about 3 cm, and the arcuate members have a diameter approximatelybetween 0.100 inches and approximately 0.500 inches and a length of atleast about 5 mm.
 7. The device of claim 1, wherein there are at leastthree elongate wire members and at least five arcuate members threadedon each of said three elongate members.
 8. The device of claim 1,wherein the arcuate members comprise an asymmetric cross-sectionalshape.
 9. A surgical implant device comprising: a plurality of elongatewire members having first and second ends, said members spaced generallyparallel to each other to form adjacent rows; a plurality of generallyuniformly shaped members threaded on each of said plurality of elongatewire members, wherein a first member has a flat top end and a flatbottom end, and has a first elongate wire member threaded therethrough,and a second member has a flat top end and a flat bottom end and has asecond elongate wire member threaded therethrough, said bottom end ofsaid first member being in contact with said top end of said secondmember, wherein said plurality of elongate wire members and plurality ofgenerally uniformly shaped members form a malleable mesh-like surfacestructure that permits liquids to flow therethrough, said plurality ofelongate wire members being spaced parallel to each other and extendingfrom and affixed to said first anchor plate and second anchor plate,said plurality of generally uniformly shaped members being freelyrotatable about said wires, and being in a stacked arrangement wheresaid flat bottom end of said second member contacts said flat top end ofsaid first generally uniformly shaped member, and wherein said generallyuniformly shaped members resist compression forces in a firstorientation and provides flexibility in an a second orientation that is90° from said first orientation, said first orientation extending alongan axis parallel to the plurality of elongate wire members; and whereinthe arcuate members are aligned in parallel to a longitudinal axis of abone and wrapped around at least a portion of a circumference of saidbone to secure a fracture site of said bone.
 10. The device of claim 9,further comprising a connecting means for engaging at least two closureedges of said device to firmly hold said device around said bone. 11.The device of claim 1,wherein said members comprise bioresorbablematerial.
 12. The device of claim 1, wherein said device has a loadsupporting capacity in a first direction and flexibility that permitstwisting of said device in a direction perpendicular to said firstdirection.
 13. The device of claim 1, further comprising a bioactivecoating on said generally uniformly shaped members, said coatingcomprising fusion promoting bone morphogenetic proteins.
 14. The deviceof claim 1, wherein said device has a bottom surface for placementagainst bone portions, said bottom surface having a convex shape along alongitudinal axis of said members.
 15. The device of claim 9,whereinsaid members comprise bioresorbable material.
 16. The device of claim 9,wherein said device has a load supporting capacity in a first directionand flexibility that permits twisting of said device in a directionperpendicular to said first direction, and wherein said device replacesan intervertebral disk and supports local stresses by transferringforces from the implant device to adjacent bone.
 17. The device of claim9, further comprising a bioactive coating on said generally uniformlyshaped members, said coating comprising fusion promoting bonemorphogenetic proteins.
 18. The device of claim 9, wherein said devicehas a bottom surface for placement against bone portions, said bottomsurface having a convex shape along a longitudinal axis of saidgenerally uniformly shaped members.
 19. The device of claim 9, whereinsaid plurality of elongate wire members have a diameter of approximatelybetween 0.010 mm and 2.00 mm, a length of at least about 3 cm, and thegenerally uniformly shaped members are arcuate and have a width ofapproximately between 0.100 inches and approximately 0.500 inches and alength of at least about 5 mm.
 20. The device of claim 9, wherein thegenerally uniformly shaped members are cylindrical.
 21. A surgicalimplant device comprising: a plurality of elongate members having firstand second ends, said members spaced generally parallel to each other toform adjacent rows; a first anchor plate attaching to at least one ofthe plurality of elongate members; a second anchor plate attaching to atleast one of the plurality of elongate members; a plurality of generallyuniformly shaped members interconnected to the plurality of elongatemembers, wherein a first uniformly shaped member has a top end and abottom end, and an aperture in at least one end of said first uniformlyshaped member, said aperture receiving at least one of said plurality ofelongate members therethrough, and wherein a second uniformly shapedmember has a top end and a bottom end, and has at least one aperturethrough which at least one of said plurality of elongate members extendstherethrough, said bottom end of said first member being in contact withsaid top end of said second member; wherein said plurality of elongatemembers and plurality of generally uniformly shaped members form amalleable mesh-like surface structure that permits liquids to flowtherethrough, said plurality of elongate members being spaced parallelto each other with at least two of said plurality of elongate membersbeing affixed to said first anchor plate, said plurality of generallyuniformly shaped members being rotatable about at least two of saidplurality of elongate members, said plurality of generally uniformlyshaped members being in a stacked arrangement that resists compressionforces in a first orientation and being in axial relationship to saidelongate members.
 22. A surgical implant device comprising: a pluralityof elongate wire members having a first and a second end, said membersspaced from each other to form adjacent rows that assist to mend; afirst anchor attaching said first end of the wire members, said anchorbeing a plate; a second anchor attaching the second ends of the wiremembers, said second anchor being straight; a plurality of generallyuniformly shaped arcuate members threaded on each of the plurality ofelongate wire members, so that they just reach, wherein a first arcuatemember has a top end and a bottom end, and has a first elongate wiremember threaded therethough, that does not bend, and a second arcuatemember has a top end and a bottom end and has a second elongate wiremember threaded therethrough, said bottom end of said first arcuatemember being in contact with said top end of said second arcuate member,and being in view wherein said plurality of elongate wire members andplurality of generally uniformly shaped arcuate members form a malleablemesh-like surface structure that permits liquids to flow therethrough,and assists one to perform, said plurality of elongate wire membersbeing spaced parallel to each other and extending therefrom, and affixedto said first anchor plate and second anchor plate, so that they do notsuccumb, said plurality of generally uniformly shaped arcuate membersbeing freely rotatable about said wires, and being in a stackedarrangement that resists compression forces that transpires, in a firstorientation and provides flexibility in a second relation, that is 90°from said first orientation.